Board of Pharmacy

Minutes – September 19, 2007

Page 2

Cannon Building / STATE OF DELAWARE / Telephone: (302) 744-4500
861 Silver Lake Blvd., Suite 203 / DEPARTMENT OF STATE / Fax: (302) 739-2711
Dover, Delaware 19904-2467 / Website: www.dpr.delaware.gov
DIVISION OF PROFESSIONAL REGULATION

MEMBERS PRESENT

Don Holst, R.Ph., Professional Member, Chair

Sebastian Hamilton, R.Ph., Professional Member, Vice Chair

Angelo Chiari, R.Ph., Professional Member

Sandra Robinson, R.Ph., Professional Member

Howard Simon, R.Ph., Professional Member

Geoffrey N. Christ, Esq., R.Ph., Professional Member

Carolyn Calio, Public Member

David W. Dryden, R.Ph., J.D., Executive Secretary

MEMBERS ABSENT

David Bonar, Public Member

Michael Hertzfeld, Public Member

DIVISION STAFF/DEPUTY ATTORNEY GENERAL

Chris Spizzirri, Deputy Attorney General

Nancy Fields, Administrative Specialist II

James Kaminski, R.Ph., Pharmacist Administrator

ALSO PRESENT

Georganne Bloch

Lucy Somer

Julienne Shank

Eric Assibey-Marfo

Barbara Bona

Chris Lowry

Tejal Patel

Gary Calabrese

Barb Knightly

Suzanne Raab-Long

Rose Bender

James McGuire

Deborah Kocinec

Al Hecmeczi

Pat Carroll-Grant

CALL TO ORDER

Mr. Holst called the meeting to order at 9:35 a.m.

REVIEW OF MINUTES

The Board reviewed the minutes of the March 19, 2008 meeting. A motion was made by Mr. Chiari, seconded by Mr. Simon to approve the minutes with edits. The motion was unanimously carried.

UNFINISHED BUSINESS

Legitimate Medical Purpose - Internet Pharmacy Proposal

Mr. Dryden reported that the Internet Bill had been amended. Mr. Collins and Mr. Dryden had prepared a draft amendment that was forwarded to the attention of the Board. The draft had language that would cover the Internet issue under the Pharmacy Act as previously purposed and discussed by the Board. The draft follows the NABP Model Rules which were agreed to by the AMA. The Board has numerous concerns with HB 270 including it was placed in the wrong area of the Code, had administrative and current law conflicts, and that many of its directives were not clear. The Board agreed and requested that Representative Hall-Long be informed that they suggested a group comprised of all stakeholders be developed to review and develop ideas that would review and propose possible amendments to current law that would better handle the internet pharmacy issues.

Gas Committee Report

Mr. Dryden reported that the Gas Committee had met on April 23, 2008. A final draft from the Committee was distributed to the Board. After review, Mr. Christ made the motion, seconded by Mr. Hamilton to approve the draft for a regulatory hearing. The motion unanimously carried.

Nursing Home Committee Report

A regulatory hearing is scheduled for this issue.

Final Check Committee Report

The Committee met on March 19, 2008. The Committee analyzed the current Regulation 5. The Committee discussed error rates associated with workflow balances, the final check’s impact on patient safety, issues of tracking, and the verification of the prescriptive processes. The Board decided that this Committee would be called the “Regulation 5 Review” in the future.

Christiana Medical Center Satellite Expansion

Mr. Helmeczi and Mr. Keaton appeared before the Board and explained CMC’s satellite expansion plans. The Board reviewed and approved of the plans provided.

Drug Disposal

Mr. Dryden reported that a pilot drug disposal had occurred at the Newark senior Center. Mr. Holst recognized that the Board of Pharmacy was thanked for their contribution to the drug disposal. The next drug disposal is scheduled for July 25, 2008 from 9 AM until 1PM at Troop 1A, at the Brandywine Town Center located just off of Naamans and Route 202 Roads.

Consent Order Review 13-06-07

The Consent order for Hugh O’Donnell was signed by the Board.

Hearing Eric Assibey 13-07-07

The Board signed the prepared order for Eric Assibey, R.Ph.

NEW BUSINESS

Pharmacist-in-Charge Interviews

Mr. Hamilton conducted the pharmacist-in-charge interview for Tejal Patel, Rose Bender, Srinivas Potluri, James McGuire and Deborah Kocinec.

Review of Pharmacy Applications

Lucy Somer appeared before the Board for approval of the floor plans for the Happy Harry’s Walgreens Pharmacy located in Hockessin. All building requirements were reviewed and agreed to by Ms. Somer. Mr. Hamilton made the motion, seconded by Mr. Christ to tentatively approve the pharmacy permit pending final inspection by the Board. The motion was carried with Mr. Holst abstaining.

Lucy Somer appeared before the Board for approval of the floor plans for the Happy Harry’s Walgreens Pharmacy located in Seaford. All building requirements were reviewed and agreed to by Ms. Somer. Mr. Hamilton made the motion, seconded by Mr. Simon to tentatively approve the pharmacy permit pending final inspection by the Board. The motion was carried with Mr. Holst abstaining.

Chris Lowry appeared before the Board for approval of the floor plans for the Rite Aid Pharmacy remodel for Seaford. These plans provided for a temporary as well as the remodeling at this same location. All building requirements were reviewed and agreed to by Mr. Mr. Hamilton made the motion, seconded by Mr. Simon, to tentatively approve the pharmacy permit pending final inspection by the Board. The motion was unanimously carried.

Gary Calabrese appeared before the Board for approval of the floor plans for the Happy Harry’s Walgreens Pharmacy (Option Care Enterprises, Inc.). All building requirements were reviewed and agreed to by Mr. Calabrese. Mr. Hamilton made the motion, seconded by Mr. Christ to tentatively approve the pharmacy permit pending final inspection by the Board. The motion was unanimously carried.

Pharmacist Licensure Review

Mr. Hamilton made a motion, seconded by Mr. Simon to approve licensure for the following individuals’ contingent upon candidates meeting all the requirements for pharmacist licensure:

Jinesh Mukundan

Joseph Szurgyjlo III

Sulochana Junnotula

Meghan Calpin

Carrie Ann Chuck

Tamara Joseph

Miriam Chehab

John Standish

Mohammad Farooqi

Heather Kleeman

Elizabeth Kukielka

Eva Alam

Kazal Bahl

Lynda Anne Finis

William Booth

Mohammed Mahgoub

Joseph McGlynn

Amylynn Pizzano

Christopher Smalley

Amit Datwani

Bonita Buesmaill

The motion was unanimously carried.

After some discussion, the Board requested Mr. Dryden to obtain further information for the candidate, Lisa Sanchez. This information will be reviewed at the next Board meeting.

After some discussion, a motion was made by Mr. Hamilton, seconded by Mr. Simon to approve Yves Brian Parker contingent upon meeting all the requirements for pharmacist licensure.

Pharmacist Consultant Interviews

Mr. Hamilton conducted the pharmacist consultant interview for Julienne Shank.

NAPLEX/MPJE Eligibility

Mr. Dryden informed the Board that Maryland and other states are allowing students to take exams before graduation. NABP has informed the Boards that they will probably not honor the scores until after the student has graduated. Board is waiting on a final decision from NABP.

Committee Reports

Joint Practice Committee – No Report

Physician’s Assistant Report – Sebastian Hamilton, R.Ph.: Mr. Hamilton advised the Committee met on 5/6/0/8, there were no applications for licensure, three for controlled substance prescriptive authority and one for prescriptive authority. The next meeting is June 13, 2008.

Newsletter – David Dryden, R.Ph., J.D, and Angelo Chiari, R.Ph. and Don Holst, R.Ph.: No report.

Legislative –David Dryden, R.Ph., J.D., and Don Holst, R.Ph., Geoffrey Christ, R.Ph., Esq.,: Mr. Holst reported that HB 386 “Collaborative Care” had been introduced before the General assembly. The Delaware Pharmacists Society had requested the Board’s support for this Bill. After review, Mr. Christ made the motion, seconded by Ms. Robinson to support the Bill as written. Mr. Hamilton opposed with the rest of the attending members voting in support of the bill. The motion carried.

Continuing Education –Michael Hertzfeld, Don Holst, R.Ph. and, Geoffrey Christ, R.Ph., Esq.: No report.

Consumer Affairs – Carolyn Calio, Michael Hertzfeld, and David Bonar: No report.

Professional Liaison – Angelo Chiari, R.Ph. and Sandra Robinson, R.Ph.: Committee met on March 25 and April 22, 2008 with DPS with Pat Carroll-Grant and presented final assessment and discussed therapeutic interchange. Awards committee presented several awards such as “Pharmacist of the Year”.

MPJE Study Committee –Angelo Chiari, R.Ph., Sebastian Hamilton, R.Ph., Sandra Robinson, R.Ph. and James Kaminski: Ms. Robinson reported that she and Jim Kaminski are still waiting on word on when to submit new questions for the MPJE.

Inspection Report

Mr. Dryden reported that 8 pharmacies, 1 clinic, 4 audits and 9 controlled substance inspections were performed in the month of April. Eleven pharmacies, 7 audits and 11 controlled substance inspections were completed during the month of March. There are four open investigations currently.

Mr. Kaminski reported to the Board of Pharmacy that controlled substance prescribing has taken a huge leap since he was involved in controlled substance audits prior to the Board transfer to the Division of Professional Regulation. There is a problem out there and without the proper monitoring and education of health care practitioners through an inspection program, the problem will continue to grow. He reported that DEA also has expressed a similar concern. Jim stated to run even a standard inspection program with the current personnel is impossible. The Board of Pharmacy expressed concerns and wanted to contact the Governor’s office explaining that personnel is needed to help resolve the problem even though current State budget concerns exist.

Board Correspondence

NABP e-News dated March 20, 2008 regarding Teleconference to Set Internet Pharmacy Standards.

NABP e-News dated March 20, 2008 regarding FDA Draft Guidance on Labeling for Hypertensive Medications.

NABP e-News dated April 16, 2008 regarding Senate Bill Passage to Restrict Distribution of Controlled Substances through Internet Pharmacies.

NABP e-News dated April 16, 2008 regarding ISMP Safe Guidelines for Automated Dispensing Cabinets.

NABP e-News dated April 16, 2008 regarding AMA Policy on Unapproved Compounded Medications.

Mr. Hamilton brought up the every other month schedule. After discussion, Mr. Hamilton made a motion, seconded by Ms. Robinson to go back to having meetings every month with the exception of July and December. The motion was carried with Mr. Holst and Mr. Christ abstaining and Ms. Calio opposing. Mr. Hamilton requested Mr. Spizzirri review the parameters and responsibilities of the Board members and staff. Mr. Hamilton requested information on influential figures that tried to influence their wishes on Board members.

Public Comment

Barbara Bonk and Eric Assibey appeared before the Board and spoke about his complaint. He apologized to the Board for his error associated with this complaint. Mr. Spizzirri reviewed the order and his rights under the order and Delaware law.

Goran Ghandi personally thanked the Board for having discussion and giving information concerning about knock boxes at the Pharmacies and suggested that they get other officials like fire department involved and tell them what the policies for knock boxes are.

Mr. Spizzirri read a letter from Ms. Barbara Gadbois to the Board in regards to Eric Assibey- Marfo’s case.

Next Scheduled Meeting

The next meeting will be held on Wednesday, June 18, 2008 at 9:30 a.m. in Conference Room B, second floor of the Cannon Building, 861 Silver Lake Boulevard, Dover, Delaware.

Adjournment

Mr. Hamilton made a motion, seconded by Mr. Christ to adjourn the meeting. The motion was unanimously carried. The meeting adjourned at 12:00 pm.

Respectfully submitted,

David W. Dryden, R.Ph., J.D.

Executive Secretary